Helsinn Healthcare S.A. et al v. Fresenius Kabi USA, LLC DC

The US Supreme Court has held that an inventor’s sale of an invention to a third party obligated to keep the invention confidential (i.e., a “secret sale”) can qualify as prior art under 35 USC Section 102(a). Helsinn Healthcare sought reversal of a Federal Circuit opinion to that effect, arguing that under the amended version of that section within the America Invents Act (AIA), an inventor’s confidential disclosure to a third party does not trigger the on-sale bar. The US Supreme Court agreed with the Federal Circuit, noting both that the amended statute included the same language, amply construed in prior case law, as the prior version and that “[t]he addition of ‘or otherwise available to the public’ is simply not enough of a change for us to conclude that congress intended to alter the meaning of the reenacted ‘on sale’”.

The US Supreme Court has agreed to review the Federal Circuit’s controversial rule that allows the disclosure of confidential sales to trigger the on-sale bar. Under 35 USC Section 102(a), as amended by the America Invents Act (AIA), a patent cannot be granted if the claimed invention was “on sale, or otherwise available to the public” outside of a one-year grace period before the “effective filing date” of the patent. In May 2017, the Federal Circuit ruled in Helsinn Healthcare v. Teva Pharmaceuticals that this restriction, known as the on-sale bar, applies when a confidential sale of a patented invention is publicly disclosed even when the invention itself remains a secret, declining to rehear that decision en banc in March 2018. On June 25, the Supreme Court granted a petition for writ of certiorari filed by Helsinn Healthcare that challenges the Federal Circuit’s ruling. The petitioner criticized that holding for “cast[ing] substantial doubt on countless patents issued pursuant to” the USPTO’s post-AIA guidance, which stated that disclosures must make an invention available to the public for the bar to apply and that it is also not triggered by an inventor’s confidential disclosures to a third party.